Wed, 25 Nov 2015 13:00:00 GMT ~ FDA Grants Fast Track Designation to Cellceutix's Brilacidin-OM for Oral Mucositis
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
Mon, 23 Nov 2015 12:30:00 GMT ~ Cellceutix Receives FDA Orphan Drug Designation for Kevetrin for the Treatment of Retinoblastoma
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
Mon, 16 Nov 2015 12:30:00 GMT ~ Cellceutix Selects Docetaxel for Combination Arm in Planned Phase 2 Trial for Ovarian Cancer
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today reports that, based ...
Wed, 11 Nov 2015 15:34:21 GMT ~ Cellceutix Completes Cohort in Kevetrin Clinical Trial; Cheers to Ocata Therapeutics
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to report that ...
Tue, 10 Nov 2015 15:51:02 GMT ~ Cellceutix Files Form 10-Q for Quarter Ended September 30, 2015
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, has filed its quarterly report ...
Fri, 30 Oct 2015 12:17:00 GMT ~ How it All Plays Out - Research on Arena Pharmaceuticals, XOMA, Ekso Bionics and Cellceutix
[Accesswire] - NEW YORK, NY / ACCESSWIRE / October 30, 2015 / Moments ago, Trader's Choice released another issue of its world-class newsletter in which it took the time to review and explain some of the most talked ...
Fri, 30 Oct 2015 11:30:00 GMT ~ Cellceutix Provides Brilacidin Update; New Class of Antibiotics to Enter Phase 3
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to provide an update ...
Mon, 26 Oct 2015 12:34:00 GMT ~ Cellceutix Due Diligence Report: False Accusations Cause Mayhem; Share Price Ready to Bounce
[Accesswire] - NEW YORK, NY / ACCESSWIRE / October 26, 2015 / Cellceutix Corp. (OTCMKTS: CTIX) a clinical stage biopharmaceutical company located in Beverly, Massachusetts developing innovative therapies in oncology, ...
Mon, 26 Oct 2015 11:40:04 GMT ~ Cellceutix to Request Meeting With FDA for Phase 2 Ovarian Cancer Study; Company's First-in-Human Study Defines the Pharmacokinetic Profile of Kevetrin
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders ...
Business Description: Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. This trial just completed its final cohort. Plans for a Ph 2/3 Ovarian Cancer Study are underway. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is currently conducting a Phase 2 clinical trial under Fast Track Designation with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is presently in Phase 2 trial. Enrollment is complete. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, recently completed a successful Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Plans for a phase 3 trial are underway w/ FDA's approval. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. Please click on the below link to find for more information on completed and active Human Clinical Trials.
Market Value: $153,621,697 a/o Nov 10, 2015 Shares Outstanding: 118,170,536 a/o Aug 26, 2015 Float: Not Available Authorized Shares: 300,000,000 a/o May 12, 2008 Par Value: 0.0001
- Start of B-ABSSSI (Phase 3) (With Fast-Track designation, per QIDP) - Completion of K (Phase 1) (more dets as to safety, efficacy) - Initiation of several K phase 2, 2/3 trials (ovarian, pancreatic, AML) (more frequent dosing likely, grant support--addtl Orphan designation/s) - Meeting w / FDA on K-pediatric retinoblastoma (rare disease) - Phase 2 B-OM update ***GRANTED FAST TRACK*** - Phase 2 P update/completion - ABX platform -- progress on anti-fungals, anti-biofilm (MTA signed for B-prophylactic testing), gram-neg compounds; GI targets (Chrons, IBD, H Supportiva)
OPERATIONS:
- Financing in place (shelf, Aspire) - 1st Shareholder meeting (Dec 15... Be it pitchfork or rose petal in feel) - NASDAQ uplisting (if $2 is maintained) - Class Action Defense (Legal) - Partners: still think this is likely farther off... Post Ph III ABSSSI for ABX... And will it be by indication or for whole platform? Kevetrin, the wildcard... As a case study, see CELG-Nurix deal (p53)
Tue, 01 Dec 2015 15:31:56 GMT ~ Cellceutix Receives Rare Pediatric Disease Designation From FDA for Kevetrin for the Treatment of Retinoblastoma
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
Mon, 30 Nov 2015 12:30:00 GMT ~ Cellceutix Retains Former Durata Executive Ronald Trust as Regulatory Affairs Consultant
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, announced today that Ronald ...
Wed, 25 Nov 2015 13:00:00 GMT ~ FDA Grants Fast Track Designation to Cellceutix's Brilacidin-OM for Oral Mucositis
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
Mon, 23 Nov 2015 12:30:00 GMT ~ Cellceutix Receives FDA Orphan Drug Designation for Kevetrin for the Treatment of Retinoblastoma
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that ...
Mon, 16 Nov 2015 12:30:00 GMT ~ Cellceutix Selects Docetaxel for Combination Arm in Planned Phase 2 Trial for Ovarian Cancer
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, today reports that, based ...
Fri, 30 Oct 2015 11:30:00 GMT ~ Cellceutix Provides Brilacidin Update; New Class of Antibiotics to Enter Phase 3
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to provide an update ...
Mon, 26 Oct 2015 11:40:04 GMT ~ Cellceutix to Request Meeting With FDA for Phase 2 Ovarian Cancer Study; Company's First-in-Human Study Defines the Pharmacokinetic Profile of Kevetrin
[Marketwired] - Cellceutix Corporation , a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders ...
Business Description: Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology and antibiotic applications. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. This trial just completed its final cohort. Plans for a Ph 2/3 Ovarian Cancer Study are underway. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is currently conducting a Phase 2 clinical trial under Fast Track Designation with its novel compound Brilacidin-OM for the prevention and treatment of Oral Mucositis. Brilacidin-OM, a defensin mimetic compound, has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is presently in Phase 2 trial. Enrollment is complete. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s key antibiotic, Brilacidin, recently completed a successful Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Plans for a phase 3 trial are underway w/ FDA's approval. Brilacidin has the potential to be a single-dose therapy or a dosing regimen that is shorter than currently marketed antibiotics for multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. Please click on the below link to find for more information on completed and active Human Clinical Trials.
Market Value: $153,621,697 a/o Nov 10, 2015 Shares Outstanding: 118,170,536 a/o Aug 26, 2015 Float: Not Available Authorized Shares: 300,000,000 a/o May 12, 2008 Par Value: 0.0001
- Completion of K Phase 1 (Solid Tumor) -- article has been submitted to a peer review journal for publication
- Initiation of several other K Phase 2, 2/3 trials -- ovarian, pediatric retinoblastoma, pancreatic, AML... this last one w/ Bologna on hold pending financing; in future trials, K to be evaluated as a monotherapy and as a combo therapy; more frequent dosing likely (eg, 2-3x week); company pursuing outside grant support; addtl Orphan designations possible beyond the two already awarded for ovarian, pediatric retinoblastoma; more expedited pathway designations possible, e.g., Breakthrough Therapy
- Start of B-ABSSSI Phase 3 -- Brilacidin represents a new class of ABX, Host Defense Protein (HDP)-Mimics; given as a single dose (in Ph 2 compared favorably w/Daptomycin); two trials, approximately 1400 patients btw them; also a Pediatric Study Plan submitted to FDA for use in children; eventual Fast-Track designation, per QIDP
- Phase 2 B-OM (oral mucositis) -- FDA has granted Fast Track status; great unmet need here; recruitment ongoing, additional enrollment sites being pursued
- ABX platform progress -- advancing work on anti-fungals (Candida species, aspergillus); anti-biofilm (MTA signed for B-prophylactic testing with a Big Rx); gram-neg compounds targeting Pseudomonas, Klebsiella, E. Coli, Acinetobacter. Carbapenem-resistant Enterobacteriaceae (CRE); GI indiciations, givien B's immunomodulatory properties (Ulcerative Proctitis/Colitis, H Supportiva); topical applications for Otic Infections
- Financing in place (shelf, Aspire) - 1st Shareholder meeting (Dec 15) - NASDAQ uplisting (if $2 is maintained) - Class Action Defense (Legal/Sullivan) - Partners: more a question of when not if as science continues to prove out -- could happen anytime. One case study, see CELG-Nurix deal (p53)